NCT02838160

Brief Summary

A randomized controlled triple blinded clinical trial with repeated measurements. The reporting of this study complies with the CONSORT (Consolidated Standards of Reporting Trials) statement for trials of non-pharmacological treatments. The first aim of the study was to evaluate the effectiveness of the three competing interventions on the critical care nurses' knowledge of, attitudes toward and adherence to 17 ventilator bundle components; the second aim was to determine the effectiveness of adherence to 17 ventilator bundle components with pre-defined ventilator bundle on the psychological factors of critical care nurses including nurses' stressors in intensive care unit (ICU), perceived stress, trait and state anxieties; the third aim was to evaluate their impact on the clinical outcomes; and the fourth aim was comparing KAP and psychological factors with clinical outcomes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

3.7 years

First QC Date

July 17, 2016

Last Update Submit

July 19, 2016

Conditions

Keywords

educational strategiesKAPpsychological and clinical outcomesintensive care unitfollow-up studyRCT

Outcome Measures

Primary Outcomes (1)

  • VAP Occurrence

    VAP Occurrence according to the clinical sings and symptoms and laboratory tests

    One year

Study Arms (3)

booklet Group

EXPERIMENTAL
Behavioral: Routine CareBehavioral: Routine care Plus the designed booklet

Oral presentations group

EXPERIMENTAL
Behavioral: Routine CareBehavioral: Routine care Plus the designed bookletBehavioral: Routine care Plus the designed booklet Plus participation in oral presentations

Clinical teaching in bedside Group

EXPERIMENTAL
Behavioral: Routine CareBehavioral: Routine care Plus the designed bookletBehavioral: Routine care Plus the designed booklet Plus participation in oral presentationsBehavioral: Routine care Plus the designed booklet Plus participation in oral presentations Plus clinical teaching in bedside

Interventions

Routine CareBEHAVIORAL

After baseline measurement, Group 1 did not receive any intervention or education.

Clinical teaching in bedside GroupOral presentations groupbooklet Group

Group 2 received only the designed booklet without any participation in the oral presentation.

Clinical teaching in bedside GroupOral presentations groupbooklet Group

Group 3 participated in oral presentations 14 days after completing self-study booklet. Interactive, standardized and mandatory oral presentations were held five times to ensure maximum attendance of the three nursing shifts.

Clinical teaching in bedside GroupOral presentations group

The Group 4 received clinical teaching in bedside after completing self-study booklet and a series of interactive, standardized and mandatory 90-120-minute oral presentations.

Clinical teaching in bedside Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Holding a degree qualification as a registered nurse
  • being a direct care provider (bedside)

You may not qualify if:

  • Nurses with less than one year experience in critical care unit
  • working less than whole study period were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amir Vahedian-azimi, Postdoc

    Baqiyatallah Universiy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doc, PhD, RN

Study Record Dates

First Submitted

July 17, 2016

First Posted

July 20, 2016

Study Start

October 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 20, 2016

Record last verified: 2016-07